Sterile surgical gloves

ABSTRACT

Natural or synthetic rubber surgical elements such as tubing, catheters, drains and gloves are &#39;&#39;&#39;&#39;lubricated&#39;&#39;&#39;&#39; so as to prevent sticking during storage, and permit easier emplacement, such as putting on the gloves by a surgeon or nurse, by applying to the surface of the rubber element finely divided polyglycolic acid powder. The polyglycolic acid powder is readily absorbed by living tissue without deleterious tissue reaction, thus minimizing tissue reaction from the transfer of the powder from the element such as a glove to internal sites in a subject.

United States Patent Semp 1 Apr. 24, 1973 STERILE SURGICAL GLOVES3,297,033 1/1967 Schmitt et a1 ..260/78.3 R 3,422,181 l/l969 Chirgwin...260/78.3 R [75 1 Inventor" g Semi 3.468.853 9/1969 Schmitt et 3|"260/783 R [73] Assignee: American Cyanamid Company, Primary Examiner-GLarkln St f d Conn, Att0rneySamuel Branch Walker [22] Filed: Feb. 23,1971 [57] ABSTRACT [2]] Appl' 117,998 Natural or synthetic rubbersurgical elements such as Related Us. Application Dam tubing, catheters,drains and gloves are lubricated so as to prevent sticking duringstorage, and permit Continuation-impart of Sen 2, Oct easieremplacement, such as putting on the gloves by a surgeon or nurse, byapplying to the surface of the rubber element finely dividedpolyglycolic acid [52] U.S.-Cl. ..2/l68, 260/783 R powden h l l fi dpowder is readily [51] Int. Cl. ..A4ld sorbed by living tissue Withoutdeleterious tissue reac- Field of Search tion, thus minimizing tissuereaction from the transfer 159 of the powder from the element such as aglove to internal sites in a subject. [56] References Cited 3 Claims, 2DrawingFigures UNITED STATES PATENTS 2,621,333 12/1952 Thomas et a]...2/l68 l2 POWDERED POL YGL YC'OLL /C AC/D- 7'0 LUBE/GATE SURFACE IPatented April 24, 1973 3,728,739

/2 POWDERED POLYGLYCOLL/C AC/D- T0 LUBR/CATE SURFACE INVENTOR. BERNARDALBERT SEMP LALWM ATTORNEY STERILE SURGICAL GLOVES RELATED APPLICATIONSThis is a continuation-in-part of Ser. No. 770,792, filed Oct. 25, 1968,now abandoned in favor hereof.

BACKGROUND OF THE INVENTION This invention relates to a natural orsynthetic rubber surgical glove which is lubricated with a biodegradabledusting powder, and to other rubber elements which contact raw tissue.Various dusting powders have been used on surgical gloves for years witha prime use being to facilitate insertion of the hands of operating roompersonnel into natural or synthetic rubber or latex gloves worn duringsurgery.

It is desirable that the powder on the gloves meet the followingrequirements:

1. It should be non-toxic to living tissue.

2. It should be biodegradable, i.e., absorbed by living tissue. This ismost important since, during surgical procedures, powder almostinevitably falls or is rubbed from the surgeons gloved hand into anexposed body cavity, and may be carried from other areas of theoperating room into the exposed body cavity by air currents.

3. The powder should have no adverse effect within the body such as thecreation of lesions (i.e., adhesions, granulomas, or such). I

4. The glove powder must be capable of sterilization by convenienthospital techniques, preferably both autoclaving and gaseous ethyleneoxide sterilization.

5. The powder must possess sufficient lubricity to permit readyinsertion of the hand into the glove and must be of sufficiently fineparticle size and have characteristics permitting such lubricity.

6. It must be reasonably priced and readily available.

7. It must be non-irritating to skin of both the surgeon or nurse andthe patient.

Talc was among the earliest surgical glove powders used by the medicalprofession. However, after the report by Antopol (Lycopodium Granuloma,Arch. Path. 16, pg. 326 (1933)) that talc caused granulomas in the body,the use of talc as a glove powder was rapidly abandoned. Talc wasreplaced by starch glove powders since starch was known to bebiodegradable and was not believed to cause granulomas or otheraggravating conditions within the body. Currently, a widely usedcommercial surgical glove powder is specially treated homogeneousamylose which contains about 2 percent magnesium oxide to preventclumping of the powder.

However, starch glove powders have a number of disadvantages. They offerhigh resistance to flow and they tend to gelatinize or agglutinate inthe presence of hot water thereby creating problems when they aresterilized in a steam autoclave. Ordinarily, the starch must be treatedin some way to minimize these properties. For example, as shown in U. S.Pat. No. 2,626,257, the starch may be treated with an agent, such asepichlorohydrin, which partially etherifies the starch in order to makethe powder free flowing after steam sterilization.

Starch is also an excellent nutrient medium for virtually all vegetativebacteria such as various pathogenic microorganisms and is objectionablefor that reason.

According to Lee and Lehman (Surgery, Gynecology, and Obstetrics 84,pgs. 689-695 (1947)), starch,

unlike talc, was completely absorbed within the peritoneal cavitywithout causing adhesions. This conclusion was challenged by Sneiersonand Woo (Annals of Surgery 132, pgs. 1045-1050 (1955)) who reported twocases of large granulomas occurring in surgical wounds as a result ofstarch powder contamination. McAdams (Surgery 39, pgs. 329-336 (1936))reported three-cases of intraperitioneal granulomas'caused by starchglove powder. The Saxens (Acta Pathology Microbiology Scand. 64, pgs.55-70 (1965)) postulated that the magnesium oxide which acts as ananticlumping material was causing the lesions. Myllarniemi and Frilander(Journal of the International College of Surgeons 44, No. 6681, pgs.677-681 (1965)) concluded that the harmful effects of starch glovepowders containing magnesium oxide might be due to a combined effect oftwo irritating constituents. Other publications which indicate theserious concern of the medical profession over granulomas traced tostarch glove powders are those of Lehman and Wilder (Journal ofAbdominal Surgery 4, No. 3, pgs. 77-80 (1962)), Webb and Regan (Archivesof Surgery 84, No. 3, pgs. 282-285 (1962)), and Walczak and Collura(American Journal of Surgery 103, No. 5, pgs. 611-612 (1962)).

Despite the aforementioned disadvantages associated with starch glovepowders, they are still used by the medical profession due to theunavailability of an improved substitute.

It is clear that a dusting powder which is readily absorbed by tissuewithout deleterious interactions is desirable, and no powder meetingthese requirements is obvious to the medical profession. The presentpowder meets all these requirements.

SUMMARY OF THE INVENTION This invention discloses a natural or syntheticrubber surgical glove having a lubricating coating of powderedpolyglycolic acid, hereinafter abbreviated as PGA. The PGA of thisinvention is completely absorbed by living tissue within days with noobservable adverse effects. In the course of biological degradation, thepolyglycolic acid powder causes no significant formation of lesions suchas adhesions or granulomas (see Example 3 hereinbelow). The powderedglove may be sterilized by autoclaving with no adverse effect upon itsdesirable properties such as, for example, its ability to flow freelywithout clumping (see Example 2). The powder can also be sterilized byother known methods such as, for example, gaseous ethylene oxidesterilization. The powder is non-toxic to living tissue, non-irritatingto the skin and can be readily prepared synthetically.

There are also significant indications that when the powder of thisinvention is applied to living tissue, an

environment is created which is bactericidal or bacteriostatic. This isindicated by the ability of wounds deliberately infected withStaphylococcus aureus to heal with. no evidence of continuing infectionwhen the wound has also been treated with the powder of this invention(see Example 4). It is further indicated by the failure of aqueoussuspensions of the powder to support the growth of organisms such asStaphyloccoccus aureous (see Example 5). It is apparent that a medicaldusting powder which is also bacteriostatic and bactericidal is a mostdesirable item.

poses larger quantities are deliberately introduced into i a wound siteand the wound closed, polyglycolic acid is provides the medicalprofession with a synthetic powder which is absorbable by living tissueand which, furthermore, is non-toxic and gives no indication of causinglesions or other aggravating conditions to any substantial degree withinthe body. The powder is readily sterilized by autoclaving or ethyleneoxide vapor and requires no elaborate pre-treatment of the powder toprevent it from clumping during such sterilization treatments.

Natural rubber or synthetic rubber surgical elements have many uses.Probably the most common is that ofa rubber glove used by a surgeon ornurse during a surgical procedure or examination ofa patient. Othersterile surgical elements may be used such as catheters, or rubberdrainage tubes which are placed in the site of a wound to permitdrainage during the healing process. Such drains are often removed assoon as the healing process proceeds to the point that a discharge is nolonger occurring. Whether the surgical elements such as a drainage tubeis to remain in the patient for a matter of several days or whether itis a surgical glove which is to be in contact with the raw tissues of awound for only a period of a few minutes, any powder on the surface ofthe rubber may be transferred into the subject. Foreign elements intissue usually cause adverse reactions. The degree of the adversereaction can vary over a wide limits but even though the reaction may beminimal, it is desired that it be reduced as far as possible.

To prevent rubber elements from sticking to each other for example theturns of a rubber tube or the folds of a surgical glove, it is desirablethat the surface be. coated with a finely divided powder to impartlubricity. Lubricity is particularly necessary with a surgeons glove inorder that the glove may be easily donned.

Obviously, it is highly desirable that any such lubricating powder becompletely non-irritating to the living tissues of the subject. Althoughthe desirability of an inert powder which is completely absorbable hasbeen recognized, a powder which would meet the requirements of lubricityand still be completely absorbable with a minimal tissue reaction underany and all conditions has not been obvious to the medical profession.

It has now been found that finely divided polyglycolic acid imparts thedesired lubricity to rubber and if present in a wound appears to becompletely absorbed by living tissue within a surgical acceptable periodof time. When used as a suture, polyglycolic acid is completely absorbedin less than 90 days in normal muscular tissue. Polyglycolic aciddusting powder whether on a drainage tube which is left in a wound or ona glove which is transferred into the wound, is normally present in thewound in but small quantities and appears to be completely undetectablein far less than 90 days. Whereas the quantities which would rub off inthe wound are comparatively small, when for test purabsorbed withminimal tissue reaction.

Additionally, the polyglycolic acid is an acid and as such has a low pH,which low pH is not favorable to the growth of deleteriousmicroorganisms, so that up until the acidity of the polyglycolic acid isneutralized by contact with other materials, the growth ofmicroorganisms is at least partially inhibited.

Although surgical elements other than surgeons gloves do haveconsiderable use, the biggest use is that of the dusting powder for thesurface of the surgeons glove. Therefore the present invention will bedescribed in greatest detail in connection with such gloves, having acoating of lubricity imparting polyglycolic acid. 7

Because the polyglycolic acid to be used on the surface of the rubbergloves and other rubber goods as a dusting powder need not bemechanically strong, and may in fact be somewhat elastic, a copolymer ofpolyglycolic acid containing lactic acid moieties, as for example, bythe copolymerization of polyglycolic acid and lactic acid is acceptable.Usually a copolymer tends to be more elastic or rubbery than ahomopolymer. Where maximum strength is desired,

frequently a homopolymer has unique characteristics, but in a powdersuch as here where tensile strength is not a criteria, a copolymer givesgood lubricity. Also the production techniques required for maximumtensile strength which are advantageous where polyglycolic acid is usedas a suture, are not necessary in a glove powder as inthe glove powder,the lubricity is the key feature and if the rubber glove having thedusting powder on its surface permits readygloving, that is permits thesurgeon to insert his hand into the glove readily, with the glovesliding onto his hand even if somewhat moist, in such fashion as to givethe feel to which the surgeon is accustomed, the powder has filled itsrequirements. It is of course necessary that the'glove slide on thesurface of the skin of the surgeon sufficiently that the thin rubbermembrane does not interfere with the sensitivity of the surgeons fingersso that the surgeon may readily feel through the glove.

Polyglycolic acid in the form of a suture has a tensile strength thatcompares favorably with that of steel on a size basis and on a weightbasis compares favorably with alloy steel but as a lubricant inconnectionwith surgical glove, the strength requirements are such thatbatches of polyglycolic acid which do not meet the tensile strengthrequirements of a suture may be pulverized and used as a perfectlysatisfactory glove powder.

DRAWINGS In the drawings:

FIG. 1 is a surgical glove having on the surface thereof polyglycolicacid.

FIG. 2 shows a user donning a surgical glove.

DESCRIPTION OF THE PREFERRED EMBODIMENTS The inventive dusting powdermay be prepared by grinding or otherwise pulverizing polyglycolic acidto the desired particle size by the use of conventional grindingequipment and techniques well known to those skilled in the art. Forexample, polyglycolic fiber or filament as prepared in U. S. Pat. No.3,297,033 is placed in an ordinary ball mill and ground for periods ofanywhere from to 48 hours. The grinding equipment is preferably groundedduring the grinding operation to prevent undesirable aggregation of theparticles caused by the static electrical charges which can accumulateon the particles during grinding. The ground material can then beremoved from the mill and vibrated through a series of screens ofvarying mesh mounted on a Ro-Tap testing sieve shaker as supplied by W.S. Tyler Co.

Particle size of the ground polymer is an important criteria inselecting a powder which is suitable for a glove powder.

It is desirable that all the powder particles be small enough to passthrough a 100 mesh screen 149 micron designation in the U. S. SieveSeries). However, small amounts (up to about 1 percent by weight) ofsomewhat larger sized particles can also be present in the powderwithout unduly adverse effect on the lubricating properties of thepolyglycolic acid powder. It is preferred that all of the powderparticles pass through a 200 mesh screen (74 micron designation in theU. S. Sieve Series). Passage through such a screen indicates theparticles contain no dimension exceeding about 74 microns.

in preparing the glove powder it is equally important that it not bemade too fine in order to minimize the escape of excessive powder intothe environment in the course of powdering the hands, surgical gloves,or other items. As discussed heretofore, the powder, on the other hand,should not be of an excessively large particle size nor should itcontain substantial amounts of exceptionally large particles since thiswill create an undesirable abrasive effect upon the skin of the handwhen the powder is used. A suitable particle size range is from about0.5 to about 149 microns with a range of from about 10 to micronspreferred.

When polyglycolic acid powder is to be sterilized in an environmentwhich contains substantial amounts of water such as, for example, in anautoclave, it is essential that the powder be contained within a packagewhich is substantially impervious to the water or steam. If thisprecaution is not taken, the water can hydrolyze the polymer causing itto become gummy and sticky. A particularly suitable water imperviouscontainer is the laminate of Mylar and polyethylene such as thatdescribed in U. S. Pat. No. 2,949,181, said patent being hereinincorporated by reference. When polyglycolic acid is packaged in a waterimpervious container such as that described above, it can be autoclavedand still retain the free flowing properties required ofa medicaldusting powder (see Example 2).

Glove powder is used in a variety of ways by the medical profession.Rubber surgical gloves are typically sold unsterile in pairs with apackage of glove powder inserted in the cuff of one of the gloves. Whenit is desired to use the gloves, the gloves and the package of glovepowder are sterilized, usually by autoclaving. The surgeon will thenopen the package of glove powder (the package usually contains about 1.5grams of powder) and pour the powder onto his hands. After working thepowder over the surface of his hands, the surgeon inserts his powderedhands into the surgical gloves, the glove powder providing the lubricityrequired to facilitate this insertion. in cases where the gloves arereusable, the gloves, at the end of the operation, will be washed,dried, inspected for holes and then repowdered, usually on both theinternal and external surfaces of the glove for subsequent reuse of theglove.

. This powdering is ordinarily accomplished by placing the gloves and aprescribed amount of glove powder in a tumbler and tumbling for asufficient period of time to powder the inside and outside surfaces ofthe glove. The powdered gloves are then repackaged, autoclaved, andpresented to the surgeon for use. Since the outside of the glove isoften powderedit is readily apparent how some of the powder may spilloff the glove and into the exposed surgical cavity ofa patient.

Disposable surgical gloves usually made of latex are also available tothe medical profession. These gloves can be offered as a unit of onepair of gloves and one package of glove powder contained in a suitablepackage. However, they are ordinarily offered as a powdered glove, i.e.,the inner and outer surfaces of the glove are pre-powdered with asuitable dusting powder. When the contents of the envelope, i.e., thegloves and the powder are sterile, the entire envelope must first beautoclaved or otherwise sterilized. At the end of the operation thegloves are discarded.

Typical glove packages are described in U. S. Pat. Nos. 3,107,786 and3,181,695.

The gloves of the present invention may be sealed in a strippableenclosure of the type shown in U. S. Pat. No. 2,949,181, there describedfor sutures, but adaptable to surgical gloves.

From the foregoing it becomes apparent that the glove powder of thisinvention can be offered either separately in a single package of asuitable material or in combination with a pair of surgical gloves ineither a sterile or unsterile condition. The powder itself may be eithersterile or non-sterile.

It is desirable when a sterile powdered surgical glove, sterile powder,or a sterile combination of a surgical glove and separately packagedglove powder is to be offered, to package the aforementioned sterileitems in a sterile inner enclosure which is then packaged in a sterileouter enclosure. The outer enclosure is provided with a strippable seal,which then allows for convenient serving of said sterile item to thepotential user by merely stripping away the outer enclosure to present atotally sterile enclosure, i.e., the outer surface as well as thecontents of the inner enclosure are sterile, containing the sterile itemto the user. The user can then open the package and remove the sterileitem therein without risk of contaminating the contents from contactwith the outer surface of the inner enclosure.

The following examples are provided to further illustrate the invention.

EXAMPLE 1 PREPARATION OF POLYGLYCOLIC ACID LUBRICATING POWDERPolyglycolic acid filaments such as typically prepared by the teachingsof U. S. Pat. No. 3,297,033 were placed in a Wiley Mill and ground forseveral hours. The ground product consisted of chopped pieces offilament ranging from 2 to 4 mils in width and 12 to 20 mils in length.The particles were flat rather than cylindrical in shape andfibrillated.

The product ground on the Wiley Mill was then ball milled for 3 hoursand examined microscopically to determine if a further breakdown in sizehad occurred. Acicular particles were found ranging in size from 0.5micron to large fragments of the chopped filaments.

Ball milling of the product was continued for another hours. At thispoint, more than 90 percent of the ground material passed through a 7mil sieve opening and the bulk of this material was found to have aparticle size ranging from less than 0.5 micron to 15 microns. Thelarger sized material which passed through the 7 mil sieve was eitheracicular with a diameter in the aforementioned range or staticaggregates. The powder retained by the 7 mil sieve was discarded.

EXAMPLE 2 STERILIZATION OF POLYGLYCOLIC ACID DUSTING POWDER The powderprepared in Example 1 was placed in a transparent envelope fabricatedfrom a laminate of the polymeric ester of ethylene glycol and terephalicacid (Mylar) and polyethylene. Such a laminate is available commerciallyfrom the Minnesota Mining and Manufacturing Co. Under the nameScotch-Pak. This laminate is known to resist penetration by water ineither liquid or vapor form. The particular laminate employed had aMylar thickness of about 1.1 to 15 mils and a polyethylene thickness ofabout 3 to 3.5 mils. The polyethylene layer of the laminate forms theinner surface of the package to facilitate heat sealing of the package.

The package was then heat sealed and placed in a standard autoclave l 5psig steam pressure, 250F.) for 1 hour. The package was then removed andopened. The package contents were free flowing and gave no indication ofbeing tacky or sticky. The powder was applied to the hands of a subjectwho then proceeded to glove his hands with a pair of rubber surgicalgloves. The performance of the powder in facilitating insertion of thehands into the gloves was quite satisfactory. Continued wearing of thegloves indicated that the powder was non-irritating to the skin.

EXAMPLE 3 IN-VIVO COMPARISON OF THE LESION PRODUCING PROPERTIES OFSTARCH AND POLYGLYCOLIC ACID DUSTING POWDER Lateral incisions were madethrough the peritoneal wall on both sides of two albino New Zealandfemale rabbits. On one side, a 5 percent solution of sterile saline andthe polyglycolic acid powder prepared in Example l was placed on theperitoneal wall. On the other side was placed an identical solution of awidely used commercial starch powder.

The rabbits were sacrificed after 3 months and gross and histologicalexaminations of the peritoneal wall were made for, and of, any lesionswhich were present. The portion of the wall treated with polyglycolicacid powder was substantially free from lesions except for the presenceof a few small nodule granulomas. The portion of the wall treated withthe starch powder, however, contained numerous readily apparent lesionsand contained several granulomas and a large adhesion.

The above results indicate that reduced formation of lesions can beexpected when the polyglycolic acid powder of this invention is usedcompared to the currently used starch powder.

EXAMPLE 4 IN-VIVO BACTERIOSTATIC AND BACTERICIDAL PROPERTIES OFPOLYGLYCOLIC ACID POWDER Two ventral incisions were made in two albinoNew I Zealand female rabbits. Both incisions were deliberatepowderappears to have in-vivo bacteriostatic and bactericidal properties.

EXAMPLES IN-VITRO BACTERIOSTATIC AND BACTER- ICIDAL PROPERTIES OFPOLYGLYCOLIC ACID POWDER Four grams of polyglycolic acid powder asprepared in Example I were added to 80 cc. of water. The pH of theresulting suspension was slightly less than 2. 10 cc. of this suspensionwere placed in a test tube labeled No. l. The pH of the remaining cc.was raised to 6 by adding approximately 0.5 gm. of sodium bicarbonate.10 cc. of the pH 6 suspension was placed in test tube No. 2. The pH ofthe remaining 60 cc. was raised'to 7 by adding approximately 0.4 gm. ofsodium bicarbonate. 10

cc. of the pH 7 suspension was placed in test tube No. 3. Test tube No.4 contained deionized water.

0.5 cc. of a 48 hour nutrient broth suspension of Staphylococcus aureuswere added to each of the 4 test tubes. The tubes were incubated at 37C.for 24 hours.

At this point, 0.4 cc. of each tube were removed and transferred to agarpour plates. These plates were incubated at 37C. for 48 hours. Resultsare shown below:

Tube No. pH Result 1 2 No Growth 2 6 Moderate Growth 3 7 Heavy Growth 4Heavy Growth The above results show that aqueous suspensions ofpolyglycolic acid powder have in-vitro bacteriostatic and bactericidalproperties. The acid pH is an important factor on gloves or in a wound,until the pH is increased, the environment'is not favorable for manymicroorganisms.

EXAMPLE 6 Powdered Gloves A group of freshly dipped latex gloves asmanufactured and before dusting were placed in a drum with about 1 gramper glove of the dusting powder of Exampie 1. The gloves were tumbledand shakened till the gloves were uniformly coated with the powderafterwhich the gloves were shaken to remove excess powder, paired andfolded and then placed between two sheets of a laminate of polyesterfilm and polyethylene. The material is described in detail in U. S. Pat.No. 2,949,181. The laminate was sealed polyethylene to polyethylene,leaving a lip and a strippable seal as described in said US. Pat. No.2,949,181 and then a group of the packaged gloves were placed in anautoclave and heated to sterilize temperature.

As so produced, the gloves could be released by stripping the package,to release the gloves in sterile condition and were then ready to bedonned by a user.

EXAMPLE 7 A group of the gloves dusted with powdered polyglycolic acidas described in the preceding example were sealed between a polyester,polyethylene laminate as above described using a strippable seal and agroup of the gloves were then placed in a ethylene oxide chamber toallow the ethylene oxide to penetrate through the laminate sea] asdescribed in more detail in US. Pat. No. 2,917,878 Canarius and Kaufman.

The individual gloves before sterilization are indicated in FIG. 1, thesurface of the glove 11 has powdered polyglycolic acid 12 spreadthereover.

FIG. 2 shows the surgeon donning the glove. The glove 13 is held by anurse whose hands 14 hold the glove with the cuff slightly stretchedwhile the hand of the surgeon 15 is inserted therein to.

lt is convenient to powder the glove with the finely dividedpolyglycolic acid before the glove is sterilized, and sterilize thepowdered glove and keep it in sterile condition until ready for use. Itis also convenient to use the powdered polyglycolic acid in sterile formto be applied to the surface of sterile gloves at the time they arebeing put on. The time of powdering the glove and the time for storingcan vary with the technique and schedules of the particular user, suchas a hospital or individual surgeon. If sterile gloves are used, asingle use disposable glove is convenient. If the gloves are to bereused, the time of applying the powder and the sterilizing can bevaried depending upon the number of gloves used in the inventoryavailable or preferences.

of 0.5 to 149 microns.

3. The glove of claim 2 in which the glove and powder are sterile, andthe powder is homopolymeric polyglycolic acid which will pass through a200 mesh screen.

2. The glove of claim 1 in which the biodegradable powder is essentiallypolyglycolic acid of a particle size of 0.5 to 149 microns.
 3. The gloveof claim 2 in which the glove and powder are sterile, and the powder ishomopolymeric polyglycolic acid which will pass through a 200 meshscreen.